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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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BIOSENSE WEBSTER INC. CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number FG540000
Device Problem Image Orientation Incorrect (1305)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/16/2020
Event Type  malfunction  
Manufacturer Narrative
The hardware investigation has begun but it has not been completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Manufacturer's ref. # (b)(4).
 
Event Description
It was reported a patient underwent a cardiac ablation procedure for paroxysmal atrial fibrillation (afib) utilizing a carto® 3 system and a map shift issue occurred. During a premature ventricular contraction (pvc) ablation procedure, carto v7 glitches were seen throughout case. Advanced reference annotation (ara) did not work from the start of the case, it would only pick up pvc intermittently. Electrocardiogram was replaced and made clean; however, ara still only worked intermittently on pvc. Throughout case could only intermittently use home, end, and delete buttons. Two maps were grouped. Fast anatomical mapping (fam) was edited for one map and lost 50% of fam from both maps and a huge geometry shift of about 10 cm was seen. The system did not display any error/warning message. No cardioversion or patient movement occurred prior to the map shift. A new map had to be created which was compared with the old map and was in a completely different location. The procedure was continued and subsequently completed without further issues. No patient consequences were reported. This event was originally considered non-reportable, however, bwi became aware of a additional information on 10/19/2020 and reassessed as mdr reportable.
 
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Brand NameCARTO 3 SYSTEM
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BIOSENSE WEBSTER INC.
33 technology drive
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER (ISRAEL) LTD.
4 hatnufah street
yokneam 20667 17
IS 2066717
Manufacturer Contact
gabriel alfageme
31 technology drive
irvine, CA 92618
949789-868
MDR Report Key10848609
MDR Text Key227972782
Report Number2029046-2020-01741
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K133916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFG540000
Device Catalogue NumberFG540000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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